Trials Sponsors Conditions Drugs Pricing

Conditions

Monomorphic Ventricular Tachycardia

Keywords

Monomorphic Ventricular TachycardiaIschemicNon-ischemicCatheter Ablation

Outcome Measures

Primary Outcomes (2)

Number of Subjects Who Experienced an ICD Shock Event.
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
12 months
Number of Subjects Who Experienced a Select Serious Adverse Event
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
30 days

Secondary Outcomes (1)

Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
12 months

Study Arms (2)

Drug with ICD/CRT-D

NO INTERVENTION

Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy

Cardiac catheter ablation with ICD/CRT-D

ACTIVE COMPARATOR

Cardiac catheter ablation with ICD/CRT-D with routine drug therapy

Device: Cardiac catheter ablation with ICD/CRT-D

Interventions

Cardiac catheter ablation with ICD/CRT-DDevice

Cardiac ablation catheter system

Cardiac catheter ablation with ICD/CRT-D

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible.

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (38)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

USC University Hospital

Los Angeles, California, 90033, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

University of California at San Francisco

San Francisco, California, 94143, United States

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Emory University Hospital

MeSH Terms

Conditions

Ischemia

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Limitations and Caveats

Low enrollment rates resulted in early termination. Therefore the study did not reach the target number of participants needed to achieve target power and statistically reliable results, and statistical hypothesis testing was not performed.

Results Point of Contact

Title: Senior Clinical Research Scientist
Organization: Abbott

Study Officials

Andrea Natale, MD
Texas Cardiac Arrhythmia Research Foundation
PRINCIPAL INVESTIGATOR
Francis Marchlinski, MD
University of Pennsylvania
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

64 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 5, 2014

Study Start

November 2014

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

Drug with ICD/CRT-D

Cardiac catheter ablation with ICD/CRT-D

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (38)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations